FDA issues complete response for dapagliflozin

AstraZeneca plc (LSE:AZN; NYSE:AZN) and Bristol-Myers Squibb Co. (NYSE:BMY) said FDA issued a complete response letter for an NDA for dapagliflozin to treat Type II diabetes. According to the partners, FDA asked for additional data to better assess the risk-benefit profile of the sodium-glucose cotransporter 2 (SGLT2) inhibitor. The partners said this includes data from ongoing trials and may require information from new clinical trials. The pharmas said they plan to work with FDA to determine next steps.

Last July, an FDA advisory committee voted 9-6 against approval of dapagliflozin, citing safety concerns (see BioCentury, July 25, 2010). ...